1. Field of the Invention
The present invention relates to the medical therapeutic industry and, more particularly, to the field of treatments for male impotence.
2. Description of the Related Art
The male penis includes a pair of corpora cavernosa located laterally within the penis, a pair of penile arteries situated deep within their respective corpora cavernosa, dorsal penal veins and a neurovascular bundle located along an upper proportion of the penis, a corpus spongiosum located along a lower portion of the penis, a urethra located within the corpus spongiosum, and stretchable skin surrounding thereabout. Generally, in the male penis, an erection is produced when arterial blood flows to the erectile tissues of the penis with the veinal return flow of blood to the body restricted so that the erectile tissues become filled or engorged with blood. The restriction is normally performed by sphincter muscles which function in response to sexual arousal. Some men have various problems, e.g., advancing age, physiological or psychological problems, or premature relaxation prior to completion of coitus. This often leaves these men unsatisfied with the sex act process.
Vacuum erection therapy is recognized as a potential remedy, preferable to many other treatments of erection dysfunction such as injections, venous and arterial surgery, or implantation of a penile prosthesis. It provides a firm erection in the shortest time, without need of sexual arousal and can be faster than pills. Vacuum constriction devices include a vacuum chamber with an open end serving as a passage for the penis and a closed end connected to a vacuum pump. To achieve an erection the penis is inserted into the open end of the vacuum chamber, which is pressed to abdomen to form an airtight seal. A vacuum is then generated in the chamber with the manually or electrically operated pump. The vacuum inside the chamber causes blood flow into the penis which thereby produces an erection. The vacuum, however, must be removed for coitus, and thus, the erection can be lost.
By the recognition that penile arteries are located primarily in the deep interior of the male penis, and the return veins are located in a sub-dermal region along the surface of the organ, it has been known to secure a band of material around the base of the penis closely adjacent a user's body to restrict the return veinal blood flow. This assists in maintaining an erection while the arterial flow remains substantially unimpeded, i.e., the arteries are deep within the organ and protected from pressure by the erectile tissue.
Over the years, various types and configurations of bands for assisting in this restriction of the return veinal blood flow have been developed. Though there are many designs, the most popular are devices that encircle the penis. Some of these bands have been developed with a readily detachable fastener which allows the band to be positioned from a substantially open-band configuration to encircle the penis and fasten to a closed configuration. This type of band, however, can often be readily detached by loosening the fastener and is generally not capable of being stretched much in the closed position without the band or fastener breaking or the fastener detaching. The lack of stretching capabilities makes the band difficult, if not impossible, to use with a ring or band loading device which assists in positioning the band over the distal end and onto a proximal portion of a penis. Additionally, these types of bands require extended visualization and significant finger dexterity in order to properly fasten such devices.
Other of these bands, do not provide a fastener, but instead allow a closed band to be stretched for positioning over a distal end of the penis and moved to the proximal end, i.e., the base of the penis for release into a penile constricted position or can be positioned using a ring or band loading device. For example, U.S. Pat. No. 4,378,008 by Osbon, Sr. titled “Erection Aid Device” describes a constricted device which encircles the penis. Also described is a band stretching and positioning tool, typically referred to as a ring loader, developed to aid in the positioning process of these bands.
Under similar principles, the vacuum device can have the constriction rings or bands placed on the vacuum chamber close to its open end and can be used to aid in the positioning process of these bands. To sustain the erection, the constriction ring or band can be preinstalled on the open proximal end of the device and can be forced to slip off onto the root of the penis. Being placed on the root of the penis, the constriction ring or band inhibits the blood flow from the penis and thus sustains the erection. After this, the vacuum is released, and the chamber is removed from the erect penis.
A problem with these types of bands, however, is that they typically require an excessive amount of lubricant to position them properly over the penis shaft, and once positioned on an erect penis, they are not easily removed, replaced, or repositioned, due to the looseness and flexibility of the stretchable skin surrounding the penis. Additionally, once the user is finished with the band and the band is in a tight constricted position, the band can be difficult to remove back over the distal end of the penis, especially over an enlarged organ and over the head (glands penis) of the penis. Also, a band left on a penis in the tight constricted position can cause pain, bruising or other problems with the penis.
Some more recent devices include elastic loops for adjusting the position of the device in an attempt to enhance comfort and improve performance of the device. For example, U.S. Pat. No. 4,539,980, by Chaney titled “Male Organ Conditioner,” describes an apparatus including a central elastic ring having a durometer number of about 55 and a pair of lateral extending integral semicircular shaped elastic loops. The central ring includes an opening which, when expended, can be passed over the penis down to its root. The relatively small ends of each of the loops are equiangularly spaced around the ring such that when the loops are stretched laterally the central ring will expand orthogonally into a square shape for positioning over the penis. The ring can be installed either manually or with a ring loader. In order to manually install the central elastic ring, the user positions two or three fingers in each loop and spreads the fingers to stretch the loops and spreads the hands from each other to deform the central elastic ring along two perpendicular planes. After positioning the central elastic ring, the user releases the ring loops to allow the ring to contract and inhibit ingress and egress of blood to and from the penis. The user then performs a forward massaging action from under the scrotum to force blood through the pre-positioned central ring to obtain to desired size and rigidity. The apparatus optionally features a second pair of loops also integral with the central elastic ring and connected coincident with the first pair of loops, the upper of the second pair of loops to provide clitoris stimulation.
Also for example, U.S. Pat. No. 5,306,227, by Osbon et al. titled “Apparatus for Augmenting Male Potency” also describes a cincture band of elastic material which also includes a protruding region positioned to provide a recess to receive the urethra of a user's male sex organ. The pair of loops are centered about 90 ninety degrees from the center of the protruding region, opposite each other, to thereby provide a user handles to manipulate the cincture band to position the protruding region over the urethra. The handles can also be used to manually expand their ring for placement over a flaccid male sex organ. The cincture band and loops can be circular in shape to prevent the introduction of sharp edges around the male sex organ and to facilitate manufacturer of the apparatus. The diameter of the loops is smaller than the cincture band in order to allow positioning of the apparatus within the open proximal end of a vacuum chamber. The apparatus can also include a pair of radially inward protruding regions within the inner diameter of the cincture band having cylindrical pressure point members consisting of an inelastic material inserted therein to provide added pressure to restrict bloodflow from the subcutaneous lateral veins without applying direct force to the center of the dorsal region. The apparatus can be inserted with use of a first vacuum device. Thereafter, the loops of the apparatus are bent forward and a second vacuum device is positioned over the apparatus and the male sex organ to provide additional erection or firmness. The first vacuum device includes a body having a smaller distal end which, in conjunction with use of a lubricant such as petroleum jelly, is utilized to help expand the apparatus for placement over the male sex organ. The first vacuum device also includes a proximal organ adapter having a larger outer diameter than the main body of the first vacuum device to allow further expansion of the apparatus for placement over the male sex organ.
Though somewhat successful in providing the user the ability to make minor adjustments to the position of the apparatus or device, these devices, however, have proved to be insufficient both in providing a user the ability to stretch the functional body of the device over an insertion device and in providing a user the ability to stretch the functional body of the device over the glands penis of the male sex organ when the male sex organ is not flaccid. During manual extension, the point-like attachment of and position of the loops or handles generally result in a user causing a nonsymmetrical deformation of the inner diameter of the apparatus or device, whereby the inner diameter is significantly increased or stretched along a plane between the center of the loops (horizontal plane) and the inner diameter is decreased in a plane perpendicular to said parallel plane (vertical plane). This can cause a tightening along the vertical plane which tends to compress the dorsal vein and neurovascular bundle and the urethra, which can result in added difficulty in removing the apparatus or device. Additional force is often required to overcome this reduction in inner diameter. Also, the nonsymmetric stretching increases the likelihood of pinching or rubbing of the skin during the stretching or contraction of the ring. Additionally, the attachment points tend to suffer structural fatigue.
Other recent devices also include handles to allow for both positioning and either independent insertion or removal of the device from the penis. For example, U.S. Pat. No. 5,873,813 by Weiss titled “Method and Apparatus for Producing and Maintaining a Penile Erection” describes an apparatus having a resilient ring member defining an inner opening through which a penis is inserted. The resilient ring member is surrounded by a cloth mesh substrate material encapsulated in an elastomer, such as medical grade silicon, which is adapted to contact the shaft of the penis. The apparatus includes a pair of spaced apart handles extending outwardly from the resilient ring member to allow the user to adjust the cross-sectional area of the inner opening housing the penis. The resilient ring is opened with the handles and inserted over a flaccid penis. The ring is then slide toward the distal end of the penis away from the shaft to capture blood released, reposition to the shaft, and again slid until the penis is of a sufficient constriction. The resilient ring is then placed at the base of the penis in the closed position to maintain the erection.
Because the handles can easily slide from the fingers of the hands of the user, these types or devices, however, have proved somewhat difficult to manipulate. These types of devices also do not lend themselves to use with a vacuum device but are instead intended to replace such device. Also, these types of devices can be uncomfortable to the user. Besides generally being designed so that one size fits all, by their nature the parts of the structure surrounding the penis and the stems for the handles must be of a resilient material such as a resilient wire.
Applicant, therefore, has recognized a need for a penile tensioning device which which allows the user to provide substantially even pressure on the sides of the penile tensioning device to radially expand a central or medial aperture of a elastic penile tensioning body with minimal geometric deformation of the shape of the aperture, and which provides easy and comfortable removal over an erect glands penis after intercourse. Also, Applicant has recognized a need to provide substantially even contraction pressure around the circumference of any erect penis. Also Applicant has recognized the need for such a non-disposable device manufactured with an ergonomic geometrical shape to provide a natural, comfortable feeling to the user and partner during use.